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GW679769 may affect liver enzymes that metabolize warfarin. This study is designed to test the extent of the GW679769 affect on Warfarin levels in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment regimen A | Experimental | In treatment regimen A subject will co-administer casopitant and warfarin over three-day period (Day 1 150 milligram per day [mg/day], Day 2 50 mg/day, Day 3 50 mg/day) and from Days 4 to 10 subject will administer only warfarin. |
|
| Treatment regimen B | Experimental | In treatment regimen B subject will co-administer casopitant 60 mg/day and warfarin for 14 days. |
|
| Treatment regimen C | Experimental | In treatment regimen C subject will co-administer warfarin and casopitant 30 mg/day for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Casopitant (GW679769) oral tablets | Drug | Casopitant will be available in the dose strength of 20,30 or 50 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels of Warfarin at Period 1: Day 9 to 14, Period 2: Day 2 & 3 and Day 5 to 16. | Period 1: Day 9 to 14, Period 2: Day 2 & 3 and Day 5 to 16. | |
| Plasma levels of casopitant at Period 2: Day 2 & 3 and Day 5 to 16. | Period 2: Day 2 & 3 and Day 5 to 16. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical lab tests monitoring of International Normalized Ratio (INR) adverse events vital signs 12 lead ECGs liver function tests | throughout the study |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Gainesville | Florida | 32605 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20220045 | Result | Kirby LC, Johnson BM, Adams LM, Eberwein DJ, Zhang K, Murray SC, Lates CD, Blum RA, Morris SR. Effect of casopitant, a novel NK-1 receptor antagonist, on the pharmacokinetics and pharmacodynamics of steady-state warfarin. J Clin Pharmacol. 2010 May;50(5):566-75. doi: 10.1177/0091270009346965. Epub 2010 Mar 10. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| NKV105097 | Individual Participant Data Set | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Warfarin oral tablets | Drug | Warfarin will be available in the dose strength of 5 mg |
|
|
| Buffalo |
| New York |
| 14202 |
| United States |
| Results for study NKV105097 can be found on the GSK Clinical Study Register. | View source |
For additional information about this study please refer to the GSK Clinical Study Register |
| NKV105097 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV105097 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV105097 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV105097 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV105097 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NKV105097 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C531951 | casopitant |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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